A Phase 1 interventional study of Investigational Tdap vaccine Formulation B and Investigational Tdap vaccine Formulation C in Tetanus Immunisation (Healthy Volunteers), Diphtheria Immunisation (Healthy Volunteers) and Pertussis Immunisation (Healthy Volunteers), sponsored by Sanofi Pasteur, a Sanofi Company. Completed at 5 sites in Canada. Open to participants aged 19 Years to 21 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-25.
Sponsored by Sanofi Pasteur, a Sanofi Company (part of Sanofi) · Phase 1, Interventional, and Prevention
Among 62 studies in Diphtheria by Sanofi Pasteur, a Sanofi Company — none open to participants now, none under way, none of them phase 3. Diphtheria · Sanofi Pasteur, a Sanofi Company.
Among the 62 studies in Diphtheria by Sanofi Pasteur, a Sanofi Company, this one is the 53rd largest by enrollment of the 57 interventional ones, is the only one that started in 2019, is one of 2 in phase 1, and was the 59th registered.
267 studies on the registry are indexed under Diphtheria; 17 are open to participants now.
This study's enrollment of 71 is below the median of 448 across 241 interventional studies indexed under Diphtheria.
Browse Diphtheria studies →None of the 62 studies in Diphtheria by Sanofi Pasteur, a Sanofi Company is open now.
Of the 10 Diphtheria studies recruiting now, 2 (20%) set no upper age limit and 8 (80%) stop at 75 or younger; 6 take children under 18; 9 take healthy volunteers.
This study: 19 Years to 21 Years · all sexes · healthy volunteers too.
The full table on the hub →62 studies; the count open now beside each. This study's row is marked.
First in 1999; this study’s year is marked. 1 started in 2019.
Median enrollment 600 across the 57 interventional studies, 7,156 across the 5 observational. Of the 62 that completed or were terminated, 39 (63%) have results posted.
Sanofi Pasteur, a Sanofi Company is the lead sponsor of 374 studies on the registry; 4 are open to participants now.
Of its 94 completed or terminated interventional studies of FDA-regulated products, 73 (78%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 62 studies in Diphtheria by Sanofi Pasteur, a Sanofi Company, from their registry updates:
Nothing recorded among them since 2026-09-25.
The primary objectives of this study are:
Study duration per participant is approximately 1 year, which will include a safety follow-up contact at 12 months after vaccination
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
IP Formulation A administration, participation in Stage 1 and Stage 2
Biological: Investigational Tdap vaccine Formulation A
IP Formulation A administration, participation in Stage 1
Biological: Investigational Tdap vaccine Formulation A
IP Formulation B administration, participation in Stage 1 and Stage 2
Biological: Investigational Tdap vaccine Formulation B
IP Formulation B administration, participation in Stage 1
Biological: Investigational Tdap vaccine Formulation B
IP Formulation C administration, participation in Stage 1 and Stage 2
Biological: Investigational Tdap vaccine Formulation C
IP Formulation C administration, participation in Stage 1 and Stage 2
Biological: Investigational Tdap vaccine Formulation C
IP Formulation D administration, participation in Stage 1 and Stage 2
Biological: Investigational Tdap vaccine Formulation D
TdaP administration, participation in Stage 1 and Stage 2
Biological: Licensed Tdap vaccine
TdaP administration, participation in Stage 1
Biological: Licensed Tdap vaccine
Pharmaceutical form:Suspension for injection Route of administration: Intramuscular
Pharmaceutical form:Suspension for injection Route of administration: Intramuscular
Pharmaceutical form:Suspension for injection Route of administration: Intramuscular
Pharmaceutical form:Suspension for injection Route of administration: Intramuscular
Pharmaceutical form:Suspension for injection Route of administration: Intramuscular
Number of participants reporting immediate adverse events (AEs)
AEs, including those related to the product administered
Time frame: Within 30 minutes post-vaccination
Number of participants reporting solicited injection sites or systemic reactions
Solicited reaction: adverse reaction prelisted in the case report book (CRB) Injection site reactions: pain, erythema, swelling Systemic reactions: fever, headache, malaise, myalgia, arthralgia, chills
Time frame: Within 7 days post-vaccination
Number of participants reporting unsolicited AEs
AEs other than solicited reactions
Time frame: Within 30 days post-vaccination
Number of participants reporting serious adverse events (SAEs)
SAEs, including adverse event of special interest (AESIs)
Time frame: Up to 12 months post-vaccination
Number of participants reporting medically attended adverse events (MAAEs)
MAAE: a new onset or a worsening of a condition that prompts the participant to seek unplanned medical advice at a physician's office or emergency department
Time frame: Up to 12 months post-vaccination
Number of participants reporting adverse events of special interest (AESIs)
AESIs are reported until the end of the safety follow-up period
Time frame: Up to 12 months post-vaccination
Number of participants reporting Grade 2 and Grade 3 laboratory parameter abnormalities
Haematological and biochemical laboratory parameters
Time frame: Within 60 days post-vaccination
Geometric mean concentrations (GMCs) of anti-pertussis antigen immunoglobulins
Anti-pertussis antigen immunoglobulins concentration will be measured by mesoscale discovery electrochemiluminescence (MSD ECL)
Time frame: From Day 0 to Day 360
GMCs of anti-diphtheria toxoid immunoglobulins
Anti-diphtheria toxoid total immunoglobulins concentration will be measured by MSD ECL
Time frame: From Day 0 to Day 360
GMCs of anti-tetanus toxoid immunoglobulins
Anti-tetanus toxoid total immunoglobulins concentration will be measured by MSD ECL
Time frame: From Day 0 to Day 360
Geometric means of antigen-specific cells
Antigen specific cells will be measured by FLUOROSPOT
Time frame: From Day 0 to Day 360
Percentages of antigen-specific cells
Antigen specific cells will be measured by FLUOROSPOT
Time frame: From Day 0 to Day 360
Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
No publications or documents are linked to this record.
Ran from Jun 2019 to primary completion in Apr 2021, 21 months.
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This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Sanofi Pasteur, a Sanofi Company →